Trial · NCT03154333

Safety and Efficacy of Diacerein 1% Ointment for Subjects With Epidermolysis Bullosa Simplex (EBS)

NCT03154333, Phase 2, Terminated, Castle Creek Pharmaceuticals, LLC; results first posted 2019-11-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy of Diacerein 1% Ointment for Subjects With Epidermolysis Bullosa Simplex (EBS). Trials, record NCT03154333. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03154333

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Efficacy of Diacerein 1% Ointment for Subjects With Epidermolysis Bullosa Simplex (EBS)
NCT number: NCT03154333
Status: Terminated
Phases: Phase 2
Enrollment: 54 participants, actual
Lead sponsor: Castle Creek Pharmaceuticals, LLC
Conditions: Epidermolysis Bullosa Simplex
Interventions: diacerein 1% ointment, A placebo ointment
First posted: 2017-05-16
Last updated: 2019-11-05
Results first posted: 2019-11-05

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Proportion of Subjects Who Achieved ≥ 60% Reduction in Body Surface Area (BSA) of EBS Lesions Within Assessment Area	Baseline to Week 8	Analysis of the proportion of subjects who achieved a ≥60% reduction in Body Surface Area (BSA) of EBS lesions within Assessment Area from Baseline to Week 8
Secondary	The Proportion of Subjects Who Achieved Success on the Investigator's Global Assessment (IGA)	Baseline to Week 8	The investigator's global assessment (IGA) is a five-point scale that is used for overall clinical assessment of severity of disease and classifies EBS-involved skin with a score ranging from 0-4. Success on the IGA was defined as ≥2-point reduction from Baseline to Visit 6 (Week 8). IGA Scoring: 0 = Clear; 1 = Near Clear; 2 = Mild; 3 = Moderate; 4 = Severe Minimum score = 0 Maximum score = 4; higher score = worse outcome

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Proportion of Subjects Who Achieved ≥ 60% Reduction in Body Surface Area (BSA) of EBS Lesions Within Assessment Area	Baseline to Week 8	All efficacy analyses were conducted using the Intent to Treat (ITT) Population that consisted of all randomized subjects who were dispensed study drug. Subjects were included in the treatment group to which they were assigned.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	The Proportion of Subjects Who Achieved Success on the Investigator's Global Assessment (IGA)	Baseline to Week 8	All efficacy analyses were conducted using the Intent to Treat (ITT) Population that consisted of all randomized subjects who were dispensed study drug. Subjects were included in the treatment group to which they were assigned.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Proportion of Subjects Who Achieved ≥ 60% Reduction in Body Surface Area (BSA) of EBS Lesions Within Assessment Area	Diacerein 1% Ointment	16	Participants
Proportion of Subjects Who Achieved ≥ 60% Reduction in Body Surface Area (BSA) of EBS Lesions Within Assessment Area	Vehicle Ointment	14	Participants
The Proportion of Subjects Who Achieved Success on the Investigator's Global Assessment (IGA)	Diacerein 1% Ointment	12	Participants
The Proportion of Subjects Who Achieved Success on the Investigator's Global Assessment (IGA)	Vehicle Ointment	7	Participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Diacerein 1% Ointment	28
Overall Study	STARTED	Vehicle Ointment	26
Overall Study	COMPLETED	Diacerein 1% Ointment	21
Overall Study	COMPLETED	Vehicle Ointment	21
Overall Study	NOT COMPLETED	Diacerein 1% Ointment	7
Overall Study	NOT COMPLETED	Vehicle Ointment	5

Source ClinicalTrials.gov

Adverse events40

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Nasopharyngitis	Infections and infestations	Diacerein 1% Ointment	4	28	4
other	Nasopharyngitis	Infections and infestations	Vehicle Ointment	2	26	2
other	Skin Infection	Infections and infestations	Diacerein 1% Ointment	3	28	4
other	Skin Infection	Infections and infestations	Vehicle Ointment	3	26	4
other	Vomiting	Gastrointestinal disorders	Diacerein 1% Ointment	4	28	5
other	Vomiting	Gastrointestinal disorders	Vehicle Ointment	1	26	1
other	Diarrhoea	Gastrointestinal disorders	Diacerein 1% Ointment	3	28	4
other	Diarrhoea	Gastrointestinal disorders	Vehicle Ointment	0	26	0
other	Pruritus	Skin and subcutaneous tissue disorders	Diacerein 1% Ointment	3	28	3
other	Pruritus	Skin and subcutaneous tissue disorders	Vehicle Ointment	1	26	1

1 to 10 of 40Source ClinicalTrials.gov

See all 40 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Diacerein 1% Ointment	0	28
Total, all-cause mortality	Vehicle Ointment	0	26
Total, other adverse events	Diacerein 1% Ointment	16	28
Total, other adverse events	Vehicle Ointment	15	26
Total, serious adverse events	Diacerein 1% Ointment	0	28
Total, serious adverse events	Vehicle Ointment	2	26

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Diacerein 1% Ointment vs Vehicle Ointment: The Proportion of Subjects Who Achieved Success on the Investigator's Global Assessment (IGA)	Trial comparisons
Diacerein 1% Ointment vs Vehicle Ointment: deaths from any cause	Trial comparisons
Diacerein 1% Ointment vs Vehicle Ointment: Proportion of Subjects Who Achieved ≥ 60% Reduction in Body Surface Area (BSA) of EBS Lesions Within Assessment Area	Trial comparisons
Diacerein 1% Ointment vs Vehicle Ointment: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03154333

GET https://conductscience.org/api/trials/v1/NCT03154333/events?page=2

API reference For AI assistants